A research study of how the medicine NNC0480-0389 taken with semaglutide works in the body of healthy Japanese me
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-jRCT2071210021
- Lead Sponsor
- Hashida Masahiro
- Brief Summary
Single doses of co-administered NNC0480-0389 s.c. (up to 30 mg) and semaglutide s.c. (0.5 mg) were well-tolerated and no safety concerns were identified in healthy Japanese male subjects. -NNC0480-0389 exposure (AUC0-oo and Cmax) increased in a dose proportional manner. -The observed half-life of NNC0480-0389 was approximately 5 days. -Semaglutide exposure (AUC0-oo and Cmax) was not significantly affected across the three NNC0480-0389 levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
Male aged 20-55 years (both inclusive) at the time of signing the informed consent.
- Both parents of Japanese descent.
- Body mass index between 20.0 kg/m2 and 24.9 kg/m2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
-Any disorder which in the investigators opinion might jeopardise subjects safety or compliance with the protocol.
- HbA1c >= 6.5% (48 mmol/mol) at screening.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of treatment emergent adverse events
- Secondary Outcome Measures
Name Time Method - Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose<br>- Maximum plasma concentration of NNC0480-0389 upon a single-dose<br>- Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose<br>- Maximum plasma concentration of semaglutide upon a single-dose